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Amgen, UCB bone drug gets Japan nod; 2 Dem. states, NYC to change health systems

Top news

* Amgen Inc. and UCB SA's osteoporosis medicine Evenity received marketing approval from the Japanese Ministry of Health, Labor and Welfare, marking its first regulatory win worldwide. Osteoporosis causes bones to deteriorate or become brittle and fragile due to low bone mass and bone tissue loss, thus increasing the risk of fractures.

Brussels-based UCB and Amgen are collaborating to develop antibody products targeting the protein sclerostin as part of a 2004 agreement. Evenity was developed in Japan by Amgen Astellas Biopharma K.K., a joint venture between Amgen and Astellas Pharma Inc., and is approved for osteoporosis patients at high risk of fracture.

* Amid the uncertainty surrounding the Affordable Care Act's future, two Democratic states and New York City have unveiled healthcare plans to reshape their individual healthcare markets and delivery systems. Washington state and New York City both released plans yesterday that would create public option programs and extend healthcare coverage to uninsured residents, while California's new governor released an executive order Jan. 7 that establishes a single-purchaser system for prescription drugs.

* Former INSYS Therapeutics Inc. CEO Michael Babich is expected to plead guilty to allegations accusing him of taking part in a scheme to pay doctors kickbacks in exchange for prescribing the company's addictive opioid drug Subsys for nonapproved uses, Reuters reported. The news comes after former Insys Vice President of Sales Alec Burlakoff pleaded guilty to similar charges in November 2018.

On the policy front

* Medicaid, the U.S. health insurance program for low-income Americans, will remain in the spotlight in 2019 as some states seek to expand coverage and others impose limits, experts said. The number of states that have expanded coverage under the program, which is jointly funded by state and federal governments, rose to 36 after Idaho, Nebraska, Virginia and Utah passed expansion plans in 2018.

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* New Wisconsin Governor Tony Evers signed two executive orders regarding healthcare on his first day in office, the Wisconsin State Journal reported. One executive order directs the state's Department of Health Services to develop a plan to expand Medicaid's coverage in Wisconsin, while the other calls on state agencies to implement plans ensuring people with pre-existing conditions get health insurance.

M&A and capital markets

* The U.S. government shutdown has partially frozen the SEC, causing biotechnology companies such as Gossamer Bio Inc., Alector Inc. and Alight Solutions LLC to move their January IPO plans to later this year, The Wall Street Journal reported.

* Takeda Pharmaceutical Co. Ltd. CEO Christophe Weber said the Japanese drugmaker is considering selling certain businesses it gained when it acquired Nycomed in 2011, Financial Times reported, adding that the company is looking to offload $10 billion in assets after closing a £46 billion acquisition of rare-disease drugmaker Shire PLC. The Times said Weber disclosed the potential asset sale in an interview during the J.P. Morgan Healthcare Conference in San Francisco.

Drug and product pipeline

* Concerns of a price war in the Chinese immuno-oncology market mounted after new entrant Shanghai Junshi Biosciences Co. Ltd. priced its melanoma therapy Tuo Yi at a cheaper rate than market leaders Merck & Co. Inc.'s Keytruda and Bristol-Myers Squibb Co.'s Opdivo. Junshi priced its PD-1 class of checkpoint inhibitor Tuo Yi at 7,200 yuan per vial, less expensive than both Merck and Bristol-Myers Squibb, even after both American heavyweights roughly halved their prices in China versus the U.S.

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* Bluebird bio Inc. is planning to sell LentiGlobin — its gene therapy for beta-thalassemia, a severe, progressive genetic disease — on an installment plan spanning five years, The Wall Street Journal reported, citing an interview with the company's CEO Nick Leschly. The drug will be priced lower than $2.1 million, according to Leschly.

Our features

Abbott Laboratories CFO says company is focused on organic growth, not M&A: During his presentation at the 2019 J.P. Morgan Healthcare Conference, Abbott Laboratories' executive vice president of finance and CFO, Brian Yoor, said M&A opportunities are not the company's main priority.

Other features

* Healthcare companies in the U.S. spent at least $29.9 billion on marketing in 2016, up from only $17.7 billion in 1997, Reuters reported, citing a U.S. study.

* The New York Times has a feature about how botox injections, often used for cosmetic purposes, may help reduce the frequency of migraines.

* STAT writes about the struggles of HIV patients whose disease fails to respond to medication.

The day ahead

Early morning futures indicators pointed to a higher opening for the U.S. market.

In Asia, Hang Seng increased 2.27% to 26,462.32, while the Nikkei 225 increased 1.10% to 20,427.06.

In Europe, around midday, the FTSE 100 increased 1.02% to 6,931.58 and the Euronext 100 was up 1.05% to 939.02.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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